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Low-­level night-­time light-­therapy for age-­related macular degeneration: a randomized clinical trial

Robinson, D. Grant, Margrain, Tom H., Dunn, Matt J., Bailey, Clare and Binns, Alison M. 2018. Low-­level night-­time light-­therapy for age-­related macular degeneration: a randomized clinical trial. Investigative Ophthalmology & Visual Science 59 (11) , pp. 4531-4541. 10.1167/iovs.18-24284

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Purpose: To investigate the safety, acceptability and effectiveness of light-­therapy on the progression of age-­related macular degeneration (AMD) over 12 months. Methods: This was a Phase I/IIa, prospective, proof-­of-­concept, single-­centre, unmasked randomized controlled trial. Sixty participants (55 to 88 years) with early AMD in the study eye and neovascular AMD (nAMD) in the fellow eye were recruited from a hospital nAMD clinic. Eligible participants were randomized (ratio 1:1) to receive light-­therapy or to an untreated control group. Light-­therapy was delivered via a light emitting mask (peak 505nm, 23 scotopic Td), which was worn each night for 12 months. Co-­primary outcome measures were disease progression (onset of nAMD or increased drusen volume beyond test-­retest limits) and change in time constant of cone dark adaptation. Other main outcomes included adverse events, compliance and subjective sleep quality data. Results: Disease progression over 12 months was seen in 38.1% (18.1-­61.6% CI) of intervention participants and 48.3% (29.4-­67.5% CI) of controls (Mantel-­Haenszel test, Common Odds Ratio = 0.763, P=0.495). A significantly larger delay in cone adaptation was observed in the intervention group (1.66 ±0.61mins) than in the control group (0.66 ±0.49 mins) over the follow-­up period. No reported AEs were deemed to be associated with the intervention. Conclusions: Whilst acceptable to the patients, light therapy did not have a substantial effect on the progression of early AMD over 12 months. Further investigation is necessary to discover the permanency and cause of the adverse effect of light therapy on dark adaptation.

Item Type: Article
Date Type: Published Online
Status: Published
Schools: Optometry and Vision Sciences
Publisher: Association for Research in Vision and Ophthalmology
ISSN: 0146-0404
Funders: College of Optometrists
Date of First Compliant Deposit: 30 July 2018
Date of Acceptance: 20 July 2018
Last Modified: 14 Feb 2020 15:00

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